The following data is part of a premarket notification filed by Ansell Healthcare Products, Llc with the FDA for Skyn Original Polyisoprene Lubricated Male Condom.
| Device ID | K160399 |
| 510k Number | K160399 |
| Device Name: | Skyn Original Polyisoprene Lubricated Male Condom |
| Classification | Condom, Synthetic |
| Applicant | Ansell Healthcare Products, LLC 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 |
| Contact | Robert Mahler |
| Correspondent | Robert Mahler Ansell Healthcare Products, LLC 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 |
| Product Code | MOL |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-12 |
| Decision Date | 2016-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813356000217 | K160399 | 000 |
| 80070907324444 | K160399 | 000 |
| 00070907217467 | K160399 | 000 |
| 80070907000003 | K160399 | 000 |
| 80070907695667 | K160399 | 000 |
| 80070907695681 | K160399 | 000 |
| 10070907000189 | K160399 | 000 |
| 10070907000172 | K160399 | 000 |
| 10070907000158 | K160399 | 000 |
| 10070907000141 | K160399 | 000 |
| 80070907324451 | K160399 | 000 |
| 30070907202075 | K160399 | 000 |
| 00813356000200 | K160399 | 000 |
| 30070907272108 | K160399 | 000 |
| 30070907229812 | K160399 | 000 |
| 00850002174083 | K160399 | 000 |
| 00850002174076 | K160399 | 000 |
| 00850002174038 | K160399 | 000 |
| 00850002174021 | K160399 | 000 |
| 80070907704765 | K160399 | 000 |
| 30070907230030 | K160399 | 000 |
| 30070907000138 | K160399 | 000 |